Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

It is too easy to fall down a rabbit hole trying to research the FDA for information when all we need is for AXIM Management to tell us in clear language what the status is for CLIA Waiver Applications/Submissions/Approvals.

When I dig down into these Substantially Equivalent comparisons I come away with more questions than answers.

AXIM has in fact modified these tests from the originals. The modifications have been beneficial. Faster more accurate results. Added a reader. Fewer tears.

Obviously AXIM and Verséa Ophthalmics can sell these tests as per the original FDA 510K.

The best policy with AXIM is to not assume anything. If AXIM management did not tell you something then it didn't happen. When I opened my eyes and stopped assuming things about AXIM it was much easier to make decisions.

In my opinion the CLIA Waiver Application process had to start over in December with the announcement of Auer Precision as manufacturing partner.

In my opinion if AXIM did not tell you that CLIA Waiver Applications have been submitted to the FDA then they probably have not been submitted. Don't assume anything unless AXIM told you. In a press release or in a 10-Q or some other form.

Verséa Ophthalmics is signing up paying customers as CLIA compliant labs. That is all we know right now.

Good luck.
Not investment advice.